Croll v. United States

594 F. Supp. 976, 1984 U.S. Dist. LEXIS 24075
CourtDistrict Court, E.D. Pennsylvania
DecidedAugust 28, 1984
DocketCiv. A. 80-4489
StatusPublished

This text of 594 F. Supp. 976 (Croll v. United States) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Croll v. United States, 594 F. Supp. 976, 1984 U.S. Dist. LEXIS 24075 (E.D. Pa. 1984).

Opinion

MEMORANDUM, INCLUDING FINDINGS OF FACT, CONCLUSIONS OF LAW AND ORDER

TROUTMAN, Senior District Judge.

I.

INTRODUCTION

This civil action was originally filed on November 20, 1980, under the Federal Tort Claims Act, 28 U.S.C. § 1346(b) and § 2671 et seq., as incorporated by the National Swine Flu Immunization Program. Act of 1976, 42 U.S.C. § 247(b). As required by 28 U.S.C. § 2402, the case has been submitted to the Court for trial without a jury.

Historically, the case was transferred to the Judicial Panel on' Multidistrict Litigation for coordinated and consolidated pretrial proceedings and has now been remanded'to this Court for further proceedings and trial. Under the Final Pre-trial Order of the transferee court, where, as here, the United States concedes that the decedent contracted Guillain-Barre Syndrome (GBS) after receiving a Swine Flue vaccination, the only issue to be decided is one of causal relationship between the Swine Flue vaccination and the GBS. No theory of liability need be established by the plaintiff to recover damages. Thus, the plaintiff need not prove negligence or other fault to recover damages.

By agreement of counsel and with the approval of the Court testimony was taken and evidence submitted on the causation issue only. If the plaintiff prevails testimony will then be taken on the issue of damages.

II. '

DISCUSSION

The first witness called by the plaintiff was Barton E. Croll, a son of the decedent, who testified as to the decedent's date of birth, date of marriage, community activities, religious activities, etc. He testified that she received the inoculation on October 8,1976, at the age of 67 years, that she later complained of tingling of the hands, *977 weakness and headaches. These symptoms first appear in the medical records when the decedent was admitted to the St. Joseph’s Hospital on February 20, 1977, and complained of weakness and numbness of the fingers and toes, commencing February 18, 1977. The nurses’ notes suggest a history of head pains commencing February 15, 1977. Importantly, the testimony of the son was expressly not offered to prove post-vaccination symptoms or complaints, but for historical purposes only. He testified as to the decedent’s hospitalization from January 18, to January 27, 1977, the implantation of radium for cancer of the uterus, the existence of high blood pressure over the years, the occurrence of phlebitis and other conditions.

The plaintiff’s decedent was diagnosed, with a reasonable degree of medical certainty, as having GBS and the defendant so concedes. Although the exact cause of GBS is unknown, epidemiological studies have established a causal relationship between the Swine Flue vaccine and GBS. GBS is also known to occur in persons who have never received the Swine Flue vaccine. Thus, plaintiff’s burden on the issue of causation was to establish, through epidemiological evidence and other evidence, that the GBS from which decedent suffered and which manifested itself seventeen to nineteen weeks after she received the Swine Flue vaccination was more probably or more likely than not caused by the vaccination.

The basic data employed by both the plaintiff’s and defendant’s experts was data gathered by the Center for Disease Control (CDC) at the time of the Swine Flue immunization program in 1976 and thereafter. The program, which began on October 1, 1976, was terminated on December 16,1976, due to concern about a disproportionate incidence of GBS in those who received vaccinations. Major studies by the CDC followed. As a result of CDC studies, the Government agreed and stipulated to liability in those cases whose GBS occurred within ten weeks of the Swine Flue inoculation. However, the plaintiffs medical expert, Dr. Goldfield, takes sincere- and outspoken exception to the methods followed by Dr. Schonberger and others who participated in the CDC program. He ultimately obtained access to the CDC data base and made his own studies and findings. In response, the Government commissioned a panel of experts, including Dr. Nathanson, also a witness in this case, called by the defendant, to reevaluate the CDC data and studies. The differences in result involve the evaluation of data, the completeness and accuracy of. that data, including the reporting or under-reporting of GBS cases with regard to the triggering event, varying degrees of under-reporting as between vaccinated and unvaccinated cases, as between early-onset cases and late-onset cases, as between mild and severe cases, as between various geographical areas and other factors, such as the effect of the termination of the program, possible confusion of GBS with other neurological disorders and other considerations. These problems and resultant considerations lead directly to the talents and expertise of an epidemiologist whose function is to develop, from available data, the most accurate comparison of GBS rates in vaccinated and unvaccinated populations, giving due consideration to other medical information and other disciplines. As stated, against this background, the plaintiff called Dr. Goldfield and the defendant called Dr. Nathanson, both experts in the field of epidemiology.

The defendant also called Dr. Elliott Mancall, a neurologist, who detailed his findings as a result of a complete review of the decedent’s medical history and records. Upon a finding that the decedent, a known hypertensive and diabetic at the time of her vaccination on October 8, 1976, did indeed suffer GBS, that significant neurological symptoms thereof did not develop until February 18, 1977, approximately nineteen weeks following inoculation, he concluded that there was, in his opinion, no causal relationship between the immunization and the GBS. He based his opinion upon the absence of neurological abnormalities during said period of time and attributed the *978 GBS to a “D & C followed by implantation of radium for treatment of carcinoma of the uterus” on January 19, 1977, pointing out that GBS “is sometimes encountered after non-specific and often minor surgical procedures” such as were here performed one month prior to the development of the symptoms.

Then followed the videotaped deposition of Dr. Neal Nathanson who concluded with “a reasonable degree of medical epidemiological certainty” that there was no causal relationship between the immunization and the development of GBS. He described the panel upon which he served which included Dr. Langmuir, an epidemiologist, Dr. Kurland, an epidemiologist, Dr. Victor, a neurologist, and Mr. Bregman, a statistician and computer expert. Assuming the development of GBS seventeen to nineteen weeks following the vaccination, he too concluded with a “reasonable degree of medical and scientific certainty” and as an expression of an “epidemiologic opinion” that the GBS from which decedent suffered “was not casually associated with the prior administration of swine flue vaccine”. He expressed this opinion with “a reasonable degree of epidemiological certainty”. Like the plaintiffs witness, Dr.

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594 F. Supp. 976, 1984 U.S. Dist. LEXIS 24075, Counsel Stack Legal Research, https://law.counselstack.com/opinion/croll-v-united-states-paed-1984.